Track & Trace Software

VIMACHEM offers a unique levels 3 to 5 serialization solution through its proprietary level 3 site management system and its partnership with Tracelink for serialization levels 4 and 5. The Vimachem level 3 site management system is fully integrated with Tracelink's Life Sciences Cloud and is managing the serialization operations at the plant level supporting multiple line management systems from the world’s leading line level equipment companies.

Level 3 Site Management System:

Vimachem Level 3 site management system is a complete serialized plant operations system that provides operational efficiencies and compliance with anti-counterfeiting requirements around the globe.

Key features include:

Project Management and Implementation Services

Our team of expert consultants will partner with your organization to provide complete end-to-end Serialization (Track & Trace) support you need to achieve cost-effective compliance. We bring world class expertise and support developed from your 10+ years of support dedicated to the Life Sciences industry.

Annual Support Through Contractual Service Level Agreements ( SLAs)

After the installation and qualification of the Vimachem Level 3 Site Management System , Vimachem will provide annual support through contractual service level agreements (SLA) for:

  • Scheduled software releases.
  • Patch releases to resolve high severity issues impacting customer use of the production software.
  • Compliance upgrades performed in the Tracelink solution requiring communication protocol alternation.
  • Advanced technical support, remote troubleshooting and issue reproduction.

Qualification Documentation & Complete Validation Plan

Standard qualification documentation in English language consisting of:

  • Operation Qualification (OQ)
  • Installation Qualification (IQ)

Complete validation plan consisting of:

  • User Requirements Specification (URS)
  • Validation Plan (VP)
  • Test Cases
  • Test Report (executed Test Cases)
  • Traceability Matrix (TM)
  • Validation Report (VR)